Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.

FDA DeterminedCause 2

OTHER/UNDETERMINED: Under Investigation by the firm

Action

Urgent Medical Device Recall Notification letters were issued on March 11, 2014 to consignees. The letter requested that customers discontinue use and quarantine any product on hand. The attached Recall Acknowledgment Form should be completed and returned to Teleflex regardless of whether affected product is on hand or not. Once received a customer service representative will contact customers with instructions on how to return the affected product. Questions should be directed to Customer Service at 1-866-246-6990.